Thermal inactivation of rotavirus

Abstract

Methods of thermally inactivating a rotavirus are provided according to the present invention which include exposing the rotavirus to a temperature in the range of about 50° C.-80° C., inclusive, for an incubation time sufficient to render the rotavirus incapable of replication or infection. The thermally inactivated rotavirus is antigenic and retains a substantially intact rotavirus particle structure. Vaccine compositions and methods of vaccinating a subject against rotavirus are provided which include generation and use of thermally inactivated rotavirus.

1 .- 28 . (canceled) 
     
     
         29 . A vaccine composition comprising antigenic thermally-inactivated rotavirus characterized by a substantially intact rotavirus particle structure. 
     
     
         30 . The vaccine composition of  claim 29 , wherein the substantially intact rotavirus particle structure is selected from the group consisting of: triple-layer rotavirus particles, double-layer rotavirus particles, and a combination of triple-layer rotavirus particles and double-layer rotavirus particles. 
     
     
         31 . The vaccine composition of  claim 29 , further comprising an adjuvant. 
     
     
         32 . The vaccine composition of  claim 31 , wherein the adjuvant is an aluminum-containing adjuvant selected from the group consisting of: AlOH, an aluminum salt; and a combination thereof. 
     
     
         33 . The vaccine composition of  claim 31 , wherein the adjuvant is AlPO 4 . 
     
     
         34 . The vaccine composition of  claim 29 , formulated for parenteral administration to a subject. 
     
     
         35 . The vaccine composition of  claim 29 , wherein the rotavirus is a human or animal rotavirus. 
     
     
         36 . The vaccine composition of  claim 29 , wherein the rotavirus is a group A rotavirus. 
     
     
         37 . The vaccine composition of  claim 29 , wherein the rotavirus is a group B rotavirus. 
     
     
         38 . The vaccine composition of  claim 29 , wherein the rotavirus is a group C rotavirus. 
     
     
         39 . The vaccine composition of  claim 29 , wherein the rotavirus is a group D rotavirus. 
     
     
         40 . The vaccine composition of  claim 29 , wherein the rotavirus is a group E rotavirus. 
     
     
         41 . The vaccine composition of  claim 29 , wherein the rotavirus is a group F rotavirus. 
     
     
         42 . The vaccine composition of  claim 29 , wherein the rotavirus is a group G rotavirus. 
     
     
         43 . The vaccine composition of  claim 29 , wherein the heat-inactivated rotavirus preparation is characterized by an amount of substantially intact viral proteins VP1, VP2 and VP6 which is substantially similar to an amount of substantially intact viral proteins VP1, VP2 and VP6 present in the starting preparation. 
     
     
         44 . The vaccine composition of  claim 29 , wherein the heat-inactivated rotavirus preparation is characterized by an amount of substantially intact viral proteins VP1, VP2, VP4, VP5, VP6 and VP7 which is substantially similar to an amount of substantially intact viral proteins VP1, VP2, VP4, VP5, VP6 and VP7 present in the starting preparation.